Detection of anti-IgE antibodies against basement membrane zone in bullous pemphigoid: a cross-sectional study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Demonstration of anti-IgE antibodies in basement membrane zone by direct immunofluorescence (DIF) microscopy
研究概览
简要总结
The present cross-sectional aims to detect anti-IgE antibodies against BMZ in patients with bullous pemphigoid
The primary objective of the study is to demonstrate anti-IgE antibodies in the basement membrane zone by direct immunofluorescence (DIF) microscopy in patients with bullous pemphigoid
The secondary objectives of the study are:
To demonstrate:
• The correlation of anti-BMZ IgE antibodies in skin biopsy with patient characteristics (age, gender, clinical manifestations, and duration of the disease)
• Bullous pemphigoid disease area index (BPDAI) score
• Association between anti-BMZ IgE antibodies in skin biopsy with eosinophil and basophil count in the peripheral blood and serum IgE and IgG (against BP180 and BP230), if done
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a clinical diagnosis consistent with bullous pemphigoid as per the standard diagnostic criteria.
- •Direct immunofluorescence (DIF) microscopy showing linear deposits of IgG and/or Complement C3 along the basement membrane zone.
- •Indirect immunofluorescence (IIF) of salt-split skin biopsy showing deposition of IgG along the basement membrane zone, if done.
排除标准
- •Severe bleeding and coagulation disorders.
- •Failure to obtain written informed consent for skin biopsy.
- •Severely immunosuppressed conditions, including acquired immunodeficiency syndrome (AIDS).
结局指标
主要结局
Demonstration of anti-IgE antibodies in basement membrane zone by direct immunofluorescence (DIF) microscopy
时间窗: During hospital stay or on OPD basis
次要结局
- • Correlation of anti-BMZ IgE antibodies in skin biopsy with patient characteristics (age, gender, clinical manifestations and duration of the disease)(• Bullous pemphigoid disease area index (BPDAI) score)
研究者
Saurodeep Basu
Kasturba Medical College Manipal